What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-06-14 compared with 2023-03-17 · 78 added, 69 removed, 158 unchanged (48% of the section changed)

44 unchanged sentences

We intend to establish agreements with distributors to get products to market quickly,

as well as to undertake and engage in our own direct marketing efforts effort as we move closer to regulatory approvals.

We will determine

the most effective method of distribution for each unique product that we include in our portfolio.

We will engage third-party research

and development firms who specialize in the creation of our products to assist us in the development of our own products, and we will

apply for trademarks and patents once we have developed proprietary products.

and undertake and engage in direct marketing efforts effort as we move closer to regulatory approvals.

We will determine the most effective

distribution method for each unique product we include in our portfolio.

We will engage third-party research and development firms who

specialize in creating products to assist us in developing our own products, and we will apply for trademarks and patents once we have

developed proprietary products.

Recent Funding

9 unchanged sentences

LPC Purchase Agreement Draws

During the six months ended January 31, 2023,

LPC purchased a total of 2,233,591 shares of our common stock for total proceeds of $441,030 pursuant to the August 14, 2020, LPC Purchase

Subsequent to January 31, 2023 and through March 17, 2023, we sold an additional 1,100,000 shares of our common stock to LPC

for total proceeds of $115,270.

As of March 17, 2023, LPC had purchased a total of 7,082,518 shares of our common stock for total proceeds

of $2,576,566 and the remaining purchase availability was $7,673,433 and the remaining shares available were 12,188,846.

During the nine months ended April 30, 2023, LPC

purchased a total of 3,533,591 shares of our common stock for total proceeds of $572,720 pursuant to the August 14, 2020, LPC Purchase

As of April 30, 2023, LPC had purchased a total of 7,282,518 shares of our common stock for total proceeds of $2,592,986 and

the remaining purchase availability was $7,657,014 and the remaining shares available were 11,988,846.

Promissory Note

1 unchanged sentence

note for $30,000 with a consultant for investor relations services with an interest rate of 8% per annum and a due date of December 31,

On December 30, 2022, this promissory note was amended to extend the maturity date to January 31, 2023.

The promissory note was amended on December 30, 2022, to extend the maturity date to January 31, 2023.

On January 31, 2023, the

3 unchanged sentences

Significant Accounting Policies and Use of

During the six months ended January 31, 2023,

there were no significant changes to our significant accounting policies and estimates are described in Note 2.

Summary of Significant

Accounting Policies included in Part II, Item 8.

of our Annual Report on Form 10-K for the year ended July 31, 2022, which was filed

with the Securities and Exchange Commission on October 31, 2022.

During the nine months ended April 30, 2023, there

were no significant changes to our significant accounting policies and estimates are described in Note 2.

Summary of Significant Accounting

Policies included in Part II, Item 8.

of our Annual Report on Form 10-K for the year ended July 31, 2022, filed with the Securities

and Exchange Commission on October 31, 2022.

Results of Operations

We do not currently sell or market any products

and we did not have any revenue in the three or six month periods ended January 31, 2023 or 2022.

We will commence actively marketing

products after the products and drugs in development have been FDA cleared or approved, but there can be no assurance, however, that we

will be successful in obtaining FDA clearance or approval for our products.

Three Months Ended January 31,

and did not have any revenue in the three or nine month periods ended April 30, 2023 or 2022.

We will commence actively marketing products

after the products and drugs in development have been FDA cleared or approved, but there can be no assurance, however, that we will be

successful in obtaining FDA clearance or approval for our products.

Three Months Ended April 30,

In-process research and development expense

3 unchanged sentences

Interest expense

Other income, net

Other expense, net

$ (1,284,104 )

$ (3,099,271 )

$ (1,815,167 )

Basic and diluted net loss per share

Six Months Ended January 31,

Nine Months Ended April 30,

In-process research and development expense

6 unchanged sentences

$ (6,438,258 )

$ (1,332,846 )

Basic and diluted net loss per share

In-Process Research and Development

In-process research and development in the three

and six-month periods ended January 31, 2023, relates to the value of the 1,000,000 shares of our Common Stock with a value of $0.17 per

share issued to Prevacus in connection with the November 2022 Option Agreement.

In-process research and development in the nine-month

period ended April 30, 2023 relates to the value of the 1,000,000 shares of our Common Stock with a value of $0.17 per share issued to

Prevacus in connection with the November 2022 Option Agreement.

Research and Development Expense

Our Research and development expense includes

expenses related to our current projects and include, clinical research, design and manufacturing, formulation, regulatory and consultants.

expenses related to our current projects, including, clinical research, design and manufacturing, formulation, regulatory and consultants.

The decreases in Research and development expense

were due to the following:

January 31, 2023 compared to three months ended

January 31, 2022

January 31, 2023 compared to six

January 31, 2022

Three months ended

April 30, 2023

three months ended

April 30, 2022

Nine months ended

April 30, 2023

nine months ended

April 30, 2022

Increase (decrease) in:

5 unchanged sentences

and prototype phase were the result of the completion of the development of the concussion drug in the fourth quarter of fiscal 2022.

The decrease in the three month ended January 31, 2023, as compared to the increase in the six months ended January 31, 2023, is the result

of the completion of dosing patients the Phase I clinical trial of our concussion drug device trial in first quarter of fiscal 2023.

The decrease in Phase I clinical trial costs in the three months ended April 30, 2023, as compared to the decrease in the nine months

ended April 30, 2023, was the result of the completion of dosing patients in the Phase I clinical trial of our concussion drug device

trial in first quarter of fiscal 2023.

General and Administrative Expense

4 unchanged sentences

were due to the following:

January 31, 2023 compared to three months ended

January 31, 2022

January 31, 2023 compared to six

January 31, 2022

Three months ended

April 30, 2023

three months ended

April 30, 2022

Nine months ended

April 30, 2023

nine months ended

April 30, 2022

Increase (decrease) in:

4 unchanged sentences

Legal and professional fees

The increases in board and stock expense were

due to the vesting of restricted stock units.

The increases in business development and investor relations were a result of increased

activities related to business development.

The decreases in wages were due to the $400,000 bonus granted to our executive officers January

$ (1,743,827 )

$ (1,329,760 )

The board and stock expense increases were due

to the vesting of restricted stock units.

The decreases in business development and investor relations were a result of decreased activities

related to business development.

The decrease in wages in the nine-month period was due to the $400,000 bonus granted to our executive

officers in January 2022.

Interest Expense

3 unchanged sentences

was as follows:

Three Months Ended January 31,

Six Months Ended January 31,

Three Months Ended April 30,

Nine Months Ended April 30,

Weighted average debt outstanding

4 unchanged sentences

of fiscal 2023.

The decreases in the weighted average interest

rates were due to the extension of maturity dates on the LGH and Tysadco notes that have flat interest rates.

The weighted average interest rate decreased due

to the extension of maturity dates on the LGH and Tysadco notes that have flat interest rates.

Other Income, net

Other income, net in the three and six months

ended January 31, 2022, included a donation in the amount of $500,000 in partnership with the Erase

PTSD Now organization and the Glenn Greenberg and Linda Vester Foundation.

Other income, net in all periods includes foreign exchange

gains and losses related to invoices denominated and paid in foreign currencies.

Net loss decreased in the three months ended January

31, 2023, compared to the same period of the prior year due to decreased research and development expense, general and administrative

Other income, net in the nine months ended April

30, 2022, included a donation in the amount of $500,000 in partnership with the Erase PTSD Now organization

and the Glenn Greenberg and Linda Vester Foundation.

Other income, net in all periods includes foreign exchange gains and losses

related to invoices denominated and paid in foreign currencies.

Net loss decreased in the three and nine months

ended April 30, 2023 compared to the same periods of the prior year due to decreased research and development expense, general and administrative

expense and interest expense as discussed above.

Net loss increased in the six months ended January 31, 2023, compared to the same period

of the prior year due to increased general and administrative expense, partially offset by decreased research and development expense

and interest expense as discussed above.

Liquidity and Capital Resources

2 unchanged sentences

The following table sets forth the primary sources and uses of cash:

Six Months Ended January 31,

Nine Months Ended April 30,

Net cash used in operating activities

12 unchanged sentences

In such case, we

may need to suspend the creation of new products until market conditions improve.

may need to suspend research and development activities until market conditions improve.

The following notes payable were outstanding:

January 31, 2023

July 31, 2022

Convertible note issued to LGH due March 31, 2023 with a flat interest rate of 8.0% of the original principal of $1,050,000 and convertible at $0.20 per share

Promissory notes issued to officers and directors due March 31, 2023 with a fixed interest rate of 8.0% per annum (see Note 10)

Convertible note issued to LGH due June 30, 2023, with a flat interest rate of 8.0% of the original principal of $1,050,000 and convertible at $0.20 per share

Promissory notes issued to officers and directors due June 30, 2023, with a fixed interest rate of 8.0% per annum (see Note 10)

Promissory note with an interest rate of 8% per annum due June 30, 2023

Tysadco convertible promissory note payable due December 31, 2023 with a flat interest rate of 8.0% of the original principal of $250,000 and convertible at $0.30 per share (see Note 11)

Mast Hill convertible promissory note due

December 13, 2023 with a fixed interest rate of 10% per annum and convertible at $0.12 per share

Tysadco convertible promissory note payable due December 31, 2023, with a flat interest rate of 8.0% of the original principal of $250,000 and convertible at $0.20 per share

Mast Hill convertible promissory note due December 13, 2023, with a fixed interest rate of 10% per annum and convertible at $0.12 per share

Unamortized debt discount and closing costs

Australian Research and Development Rebate

In the first six months of fiscal 2023, we incurred

In the first nine months of fiscal 2023, we incurred

$698,041 of expenses related to our Phase I clinical trial of our concussion drug device combination that are eligible for the Australian

6 unchanged sentences

related to our Phase I human clinical trial during July, August and September 2022.

On February 10, 2023, we received a goods and

service tax refund, which was accrued as part of our research and development rebate due from the Australian government, in the amount

of $9,231 related to our Phase I human clinical trial during October, November and December 2022.

Inflation did not have a material impact on our

7 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis